FDA.reportPublic FDA data

Biopsy forceps

Primary DI
06974880993131
Brand
Biopsy forceps
Company
Suzhou AcuVu medical technology Co., Ltd.
Model
RSI-370-7-C
Device description
The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the uterine cavity.
Published
2025-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974880993138PackageGS11In Commercial Distribution
26974880993135PackageGS15In Commercial Distribution
06974880993131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697488099313816974880993138
2697488099313526974880993135
06974880993131069748809931316974880993131

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6178344997frank.huang@sz-acuvu.com

Regulatory Flags#

DUNS number
705464292
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974880994053Manual Tissue Removal DeviceMTRD-9-3252026-07-27
06974880994084Manual Tissue Removal DeviceMTRD-9-3702026-07-27
06974880994343Omni® Hysteroscopic GrasperOMNI-G-DSI-0012026-04-17
06974880991441HTx Disposable HysteroscopeHTx60t2025-05-08
06974880991458HTx Disposable HysteroscopeHTx60-L2025-05-08
06974880993124Single action scissorsRSI-370-7-A2025-05-08
06974880993148Serrated forcepsRSI-370-7-D2025-05-08
06974880993155Alligator grasperRSI-370-7-E2025-05-08
06974880993162Hook grasper RSI-370-7-G2025-05-08
06974880993179Single action scissorsRSI-370-9-A2025-05-08
06974880993186Biopsy forcepsRSI-370-9-C2025-05-08
06974880993193Serrated forcepsRSI-370-9-D2025-05-08
06974880993209Alligator grasperRSI-370-9-E2025-05-08
06974880993216Hook grasper RSI-370-9-G2025-05-08
06974880993407HTx Disposable HysteroscopeHTx40-L2025-05-08
26974880991445HTx Disposable HysteroscopeHTx60t2025-05-08
26974880991452HTx Disposable HysteroscopeHTx60-L2025-05-08
06974880991632HTx Disposable HysteroscopeHTx60c2025-05-08
16974880993121Single action scissorsRSI-370-7-A2025-05-08
16974880993138Biopsy forcepsRSI-370-7-C2025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422844MillenniumAvalign Technologies, Inc.HTD2026-08-03
B382SD4121490Surgical DirectSurgical Direct, Inc.HTD2026-08-03
00190776422349MillenniumAvalign Technologies, Inc.HTD2026-07-31
00810143904567SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906158SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906349SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906356SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906448SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931029SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931036SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931043SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931050SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931913SURGIPROSSurgipros, LLCHTD2026-07-31
00810212934907SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935133SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935638SURGIPROSSurgipros, LLCHTD2026-07-31
B382S028531010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S028531030Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S28531800Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S8541010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382SD1355500Surgical DirectSurgical Direct, Inc.HTD2026-07-31
00840277133724Innomed, Inc.INNOMED, INC.HTD2026-07-29
B382SD92022614E0Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9203561000Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9206011020Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B3825SD918621130Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493210Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493220Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493230Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD91849612000Surgical DirectSurgical Direct, Inc.HTD2026-07-28